Sanbor Medical Xiamen, Inc. · 89-08 · CHINA
For Sanbor Medical Xiamen, Inc., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered; date published is 03/01/2011; address is 1776 Lv Ling Road , Xiamen, Fujian CHINA, verified against its source on 2026-09-30.
- Firm
- Sanbor Medical Xiamen, Inc. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- 1776 Lv Ling Road , Xiamen, Fujian CHINA verified
- Date published
- 03/01/2011 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered each item verified
- Product
- ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Sanbor Medical Xiamen, Inc. Date Published : 03/01/2011 1776 Lv Ling Road , Xiamen, Fujian CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System Notes: Class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html